Should data monitoring committees assess efficacy when considering safety in trails in acute stroke?

QR Code

Should data monitoring committees assess efficacy when considering safety in trails in acute stroke?

The primary role of a trials Data Monitoring Committee (DMC) is to ensure the safety of enrolled patients. In stroke trials, safety is monitored typically by comparing death and stroke specific events between treatment groups. DMCs may also have the remit for monitoring efficacy depending on the aim...

Full description

Bibliographic Details
Main Authors:	Bath, Philip M.W., Gray, Laura J., Wahlgren, Nils-Gunnar
Format:	Article
Published:	Blackwell Publishing 2007
Subjects:	stroke; clinical trial; data monitoring committees; functional outcome; efficacy; impairment
Online Access:	https://eprints.nottingham.ac.uk/544/

Similar Items

Optimising the analysis of stroke trials
by: Gray, Laura Jayne
Published: (2008)

Can we improve the statistical analysis of stroke trials? Statistical re-analysis of functional outcomes in stroke trials
by: Bath, Philip M.W.
Published: (2007)

Route of feeding as a proxy for dysphagia after stroke and the effect of transdermal glyceryl trinitrate: data from the efficacy of nitric oxide in stroke randomised controlled trial
by: Woodhouse, Lisa J., et al.
Published: (2017)

Sex differences in quality of life in stroke survivors. Data from the Tinzaparin in Acute Ischaemic Stroke Trial (TAIST)
by: Gray, Laura J., et al.
Published: (2007)

The Insulin Resistance Intervention after Stroke trial: a perspective on future practice and research
by: Bath, Philip M.W., et al.
Published: (2016)

Can we improve the statistical analysis of stroke trials? Statistical re-analysis of functional outcomes in stroke trials
by: Bath, Philip
Published: (2007)

The effect of different combinations of vascular, dependency and cognitive endpoints on the sample size required to detect a treatment effect in trials of treatments to improve outcome after lacunar and non-lacunar ischaemic stroke
by: Makin, Stephen D.J., et al.
Published: (2017)

Relationship between therapeutic changes in blood pressure and outcomes in acute stroke: a metaregression
by: Geeganage, Chamila, et al.
Published: (2009)

An evaluation of screening measures for cognitive impairment after stroke
by: Blake, Holly, et al.
Published: (2002)

Testing devices for the prevention and treatment of stroke and its complications
by: Bath, Philip M.W., et al.
Published: (2014)

The Virtual International Stroke Trials Archive
by: Myzoon, Ali, et al.
Published: (2007)

Significant variation in mortality and functional outcome after acute ischaemic stroke between western countries: data from the 'Tinzaparin in Acute Ischaemic Stroke Trial' (TAIST)
by: Gray, Laura J., et al.
Published: (2006)

Post-stroke dysphagia: clinical and radiological outcomes and efficacy
by: Everton, Lisa
Published: (2021)

Amphetamine increases blood pressure and heart rate but has no effect on motor recovery or cerebral haemodynamics in ischaemic stroke: a randomized controlled trial (ISRCTN 36285333)
by: Sprigg, Nikola, et al.
Published: (2007)

Statistical analysis plan for the ‘Efficacy of Nitric Oxide in Stroke’ (ENOS) trial
by: Bath, Philip M.W., et al.
Published: (2014)

Pharyngeal electrical stimulation for treatment of dysphagia in subacute stroke
by: Bath, Philip M.W., et al.
Published: (2016)

Exploring the impact of individual-level attributes on fidelity and return-to-work outcomes in a complex rehabilitation trial
by: Powers, Kathryn
Published: (2024)

Post-stroke visual impairment: a systematic literature review of types and recovery of visual conditions
by: Hepworth, Lauren, et al.
Published: (2015)

Clinical and radiological associations with outcome after a severe stroke
by: Subramanian, G.
Published: (2020)

High blood pressure in acute stroke: to treat or not to treat
by: Sare, Gillian M., et al.
Published: (2007)

Protocol for process evaluation of a randomised controlled trial of family-led rehabilitation post stroke (ATTEND) in India
by: Liu, Hueiming, et al.
Published: (2016)

Adjudicating outcomes in stroke trials
by: Godolphin, Peter J.
Published: (2019)

Relationship between race and outcome in Asian, Black and Caucasian patients with spontaneous intracerebral haemorrhage: data from the Virtual International Stroke Trials Archive (VISTA) and Efficacy of Nitric Oxide in Stroke trial (ENOS)
by: Krishnan, Kailash, et al.
Published: (2018)

Antiplatelet therapy following ischaemic stroke: continue or change pre-existing therapy?
by: Mazlan-Kepli, Wardati, et al.
Published: (2017)

Tranexamic acid for spontaneous intracerebral hemorrhage: a randomized controlled pilot trial (ISRCTN50867461)
by: Sprigg, Nikola, et al.
Published: (2014)

Lipid-lowering pretreatment and outcome following intravenous thrombolysis for acute ischaemic stroke: a post hoc analysis of the enhanced control of hypertension and thrombolysis stroke study trial
by: Minhas, Jatinder S., et al.
Published: (2018)

Statistical reanalysis of vascular event outcomes in primary and secondary vascular prevention trials
by: Woodhouse, Lisa Jane
Published: (2022)

The assessment of functional communication in patients with acquired communication problems: the development of the Derby Functional Communication Scale
by: Ditchfield, Jennifer A.
Published: (2008)

Granulocyte-colony-stimulating factor mobilizes bone marrow stem cells in patients with subacute ischemic stroke: the Stem Cell Trial of Recovery EnhanceMent After Stroke (STEMS) Pilot Randomized, Controlled Trial (ISRCTN 16784092)
by: Sprigg, Nikola, et al.
Published: (2006)

Audit committee and audit fees in high regulated firms: moderating role of regulatory oversight / Norziaton Ismail Khan
by: Ismail Khan, Norziaton
Published: (2019)

Board Monitoring, Audit Committee Effectiveness and Financial Reporting Quality
by: SHAN, YIBING
Published: (2017)

The Presence of Audit Committee Improves Transparency In Financial Reporting Process: Comparison between Merged and Unmerged FTSE 100 Companies
by: Pasupathi, Swarna
Published: (2006)

The DRESS trial: a feasibility randomized controlled trial of a neuropsychological approach to dressing therapy for stroke inpatients
by: Walker, Marion F., et al.
Published: (2012)

Interventions for deliberately altering blood pressure in acute stroke
by: Bath, Philip M.W., et al.
Published: (2014)

Audit Committee Characteristics and Accounting Conservatism
by: Sultana, Nigar
Published: (2015)

Safety and efficacy of intensive vs. guideline antiplatelet therapy in high-risk patients with recent ischemic stroke or transient ischemic attack: rationale and design of the Triple Antiplatelets for Reducing Dependency after Ischaemic Stroke (TARDIS) trial (ISRCTN47823388)
by: Beridze, M., et al.
Published: (2015)

Earnings conservatism and audit committee financial expertise
by: Sultana, Nigar, et al.
Published: (2015)

Design and implementation of Pharyngeal electrical Stimulation for early de-cannulation in TRACheotomized (PHAST-TRAC) stroke patients with neurogenic dysphagia: a prospective randomized single-blinded interventional study
by: Dziewas, Rainer, et al.
Published: (2017)

An empirical analysis of the relationship between Board and Committee activities and Bank Risk
by: Ioannou, Kyriaki
Published: (2017)

Effect of aspirin, clopidogrel and dipyridamole on soluble markers of vascular function in normal volunteers and patients with prior ischaemic stroke
by: Zhao, Lian, et al.
Published: (2006)